RecruitingEarly Phase 1NCT05176418

IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate

Sponsor

Yale University

Enrollment

70 participants

Start Date

Sep 9, 2022

Study Type

INTERVENTIONAL

Conditions

Nicotine Dependence

Summary

This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.

Eligibility

Min Age: 21 YearsMax Age: 55 Years

Inclusion Criteria3

Female and male, aged 21 to 55 years;
past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests
women, -using acceptable birth control methods.

Exclusion Criteria6

History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
for women, pregnant as determined by pregnancy screening, or breast feeding
seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.

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Interventions

DRUGlow dose Nicotine

IV nicotine infused over different delivery rates

DRUGhigh dose Nicotine

IV Nicotine infused over different delivery rates

Locations(1)

VA Healthcare System

West Haven, Connecticut, United States

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NCT05176418

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